Registry for monitoring RSV vaccine effects during pregnancy
CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR)
This study is tracking the health of pregnant people who received the RSV vaccine in late pregnancy to see if it affects their pregnancy outcomes and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2062 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | CorEvitas Research network |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT06521944 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the risks of adverse pregnancy outcomes, such as preterm birth and hypertensive disorders, following exposure to the RSV vaccine during late pregnancy (between 32 and 36 weeks of gestation). The study will collect data on various maternal and neonatal outcomes to evaluate the safety of the vaccine in this specific population. Participants will include pregnant individuals who have received the RSV vaccine within the specified gestational period, and the registry will track their health outcomes and any complications that may arise. The findings will help inform the safety profile of the RSV vaccine for pregnant individuals and their infants.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 to 50 who are at least 32 weeks gestation and have received the RSV vaccine during the specified timeframe.
Not a fit: Patients who have received the RSV vaccine before 32 weeks of gestation or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical safety information regarding the use of the RSV vaccine in pregnant individuals, potentially leading to improved maternal and infant health outcomes.
How similar studies have performed: While this study focuses on a specific vaccine and population, similar observational studies have successfully assessed vaccine safety in pregnant individuals, providing a foundation for this research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals must meet the following inclusion criteria to be eligible for inclusion in the study: 1. A resident of the US at enrollment 2. 18 to 50 years of age at enrollment 3. Gestational age of ≥32 weeks, 0 days at enrollment 4. If exposed to RSV vaccine, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation 5. Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant IRB/independent ethics committee, verbal consent indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study 6. Authorization obtained for the relevant HCP(s) to provide data to the registry 7. Contact information available (for participant and HCPs) Exclusion Criteria: * Individuals meeting any of the following criteria will not be included in the study: 1. Receipt of an RSV vaccine during pregnancy before 32 weeks, 0 days gestation 2. Multi-fetal pregnancy 3. Enrolled in the RSV-PR with a previous pregnancy
Where this trial is running
Wilmington, North Carolina
- Ppd — Wilmington, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ronna Chan, PhD, MPH — PPD, Part of Thermo Fisher Scientific
- Study coordinator: Ronna Chan, PhD, MPH
- Email: RSV@corevitas.com
- Phone: 1-800-616-3791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.